- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01620320
Stress Echocardiography Versus Coronary Angiography for Left Main Stenosis Detection (ESTRIE-TC)
June 24, 2013 updated by: Paul Farand, Université de Sherbrooke
Évaluation de l'Echographie de Stress Par Comparaison à la Coronarographie Comme Outil Non Invasif de détection de la resténose Intra endoprothèse du Tronc Commun
Left main stenosis use to be treated by bypass but with the improvement of angioplasty techniques, an increasing number of patients are submit to left main coronary angioplasty.
Consequences of left main intra stent stenosis can be disastrous yet, for the moment, no precise recommendation concerning the follow up of these patients exist.
The investigators ought to determine if stress echocardiography can predict left main intra stent stenosis as well (non inferiorly)as control angiography that use to be done.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Detailed Description
All patients of the study will pass coronary angiogram and stress echocardiography (treadmill of dobutamine).
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Quebec
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Sherbrooke, Quebec, Canada, J1H 5N4
- Centre Hospitalier Universitaire de Sherbrooke, departement de cardiologie
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients presenting to teaching hospital or stent from community hospitals to teaching hospital and having left main angioplasty
Description
Inclusion Criteria:
- patients over 18 years old able to give consent and having had left main angioplasty.
Exclusion Criteria:
- Bypass on the left anterior descending coronary artery or left circumflex (" protected left main ")
- Treating physician judge that angiography need to be done straightaway
- Follow up elsewhere than the CHUS
- Patient refusal
- Pregnant women
- Stress echo contraindication(Severe high blood pressure or malignant arrhythmia)or condition that limits interpretation (Left bundle branch block or pacemaker rhythm)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Stress echography
Nine to twelve months after their left main angioplasty, patients will go through a stress echo and then the usual control angiography (done routinely in most patient in our center).
Patients will act as their own control.
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Patients able to exercise will have a treadmill test + echography; the others will have a dobutamine echography.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Correlation between stress echocardiography results for the detection of left main prosthesis stenosis with coronary angiogram results.
Time Frame: 9 to 12 months after left main angioplasty
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9 to 12 months after left main angioplasty
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul Farand, Cardiologue, Centre de recherche du Centre hospitalier Universitaire de Sherbrooke
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2010
Primary Completion (Anticipated)
July 1, 2012
Study Completion (Anticipated)
July 1, 2013
Study Registration Dates
First Submitted
July 16, 2010
First Submitted That Met QC Criteria
June 14, 2012
First Posted (Estimate)
June 15, 2012
Study Record Updates
Last Update Posted (Estimate)
June 26, 2013
Last Update Submitted That Met QC Criteria
June 24, 2013
Last Verified
June 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Pathological Conditions, Anatomical
- Coronary Artery Disease
- Myocardial Ischemia
- Coronary Disease
- Constriction, Pathologic
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Protective Agents
- Adrenergic Agonists
- Cardiotonic Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Adrenergic beta-1 Receptor Agonists
- Dobutamine
Other Study ID Numbers
- projet #10-011
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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